First FDA-Approved Xenotransplantation Device
CAMBRIDGE, Mass., Oct. 29 /PRNewswire-FirstCall/ -- Genzyme Corporation
(Nasdaq: GENZ) announced today that the U.S. Food and Drug Administration
(FDA) has granted Epicel(TM) (cultured epidermal autografts) marketing
approval under the Humanitarian Device Exemption (HDE) for the treatment of
life-threatening wounds resulting from severe burns. It is a product that
can provide permanent skin replacement for burn victims, and is made from a
patient's own skin cells and then grown on a layer of mouse cells to
enhance growth. Epicel is the first xenotransplantation-classified product
to be approved in the U.S. because of its inclusion of animal cells.
"We are pleased that the FDA has recognized the importance of Epicel
for patients with severe burns," said Alicia Secor, vice president and
general manager of the Biosurgical Specialties group within Genzyme that
manufactures Epicel. "Epicel has played a critical role in the recovery
process of hundreds of patients who have suffered through the trauma of
life-threatening burns."
Epicel has been used in more than 1,000 patients with burn injuries
since it was introduced in 1988. The product had been considered a banked
human tissue until 1996 when FDA announced that manipulated autologous
cell-based products used for structural repair or reconstruction required
regulatory oversight. Genzyme applied for regulatory approval of Epicel in
1999.
Epicel is supplied in grafts, which each consist of a sheet of cultured
epidermal cells attached with stainless steel surgical clips to a backing
of petrolatum gauze. Enough skin can be grown from a biopsy the size of a
postage stamp to cover the entire body. The process takes approximately 16
days and the skin grafts integrate with surrounding tissue 3 to 4 weeks
after surgery.
"Epicel has been the most important advance in burn care for the
coverage of large total body surface area burn wounds in this decade," said
Dr. Rajiv Sood, medical director, Richard M. Fairbanks Burn Center, Indiana
University School of Medicine.
About Epicel
Epicel is indicated for use in patients who have deep dermal or full
thickness burns comprising a total body surface area of greater than or
equal to 30 percent. It may be used in conjunction with split-thickness
autografts -- another type of skin graft taken from a patient's body to
treat the burned area -- or alone in patients for whom these autografts may
not be an option due to the severity and extent of their burns. The
effectiveness of the device for this use has not been demonstrated.
Epicel is contraindicated in patients with known hypersensitivity to
agents used in the manufacture of Epicel. Epicel should not be used in
patients with a known history of anaphylaxis to vancomycin or amikacin.
Epicel is cultured in media containing vancomycin and amikacin. Trace
quantities of these antibiotics may adhere to the Epicel autograft.
Epicel should not be used in patients with known sensitivities to
materials of bovine or murine origin. The cell culture medium used in the
culture of Epicel contains bovine serum and the cells co-cultured with
murine 3T3 fibroblasts. The medium used to package and transport Epicel
does not contain serum; however, trace quantities of bovine derived
proteins may be present. This tissue is intended for autologous use and has
not been tested for biohazards. Health care providers should handle this
product as if infectious agents are present.
During the Epicel manufacturing, patient's cells are co-cultured with
mouse cells. Although the mouse cells have been tested and found to be free
of bacteria, fungi and virus, an infection can not be excluded. It is also
possible that symptoms of an infection may not be seen for months or years.
To date, Genzyme Biosurgery is not aware of any infections related to mouse
cells. As a safety measure, the Epicel treated patients are precluded from
donation of blood or blood parts, tissue, breast milk, egg, sperm, or other
body parts for use in humans.
About Genzyme
One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people with
serious diseases. Since 1981, the company has grown from a small start-up
to a diversified enterprise with more than 9,500 employees in locations
spanning the globe and 2006 revenues of $3.2 billion. In 2007, Genzyme was
chosen to receive the National Medal of Technology, the highest honor
awarded by the President of the United States for technological innovation.
In 2006 and 2007, Genzyme was selected by FORTUNE as one of the "100 Best
Companies to Work for" in the United States.
With many established products and services helping patients in nearly
90 countries, Genzyme is a leader in the effort to develop and apply the
most advanced technologies in the life sciences. The company's products and
services are focused on rare inherited disorders, kidney disease,
orthopaedics, cancer, transplant, and diagnostic testing. Genzyme's
commitment to innovation continues today with a substantial development
program focused on these fields, as well as immune disease, infectious
disease, and other areas of unmet medical need.
Genzyme's press releases and other company information are available at
http://www.genzyme.com and by calling Genzyme's investor information line
at 1-800-905-4369 within the United States or 1-703-797-1866 outside the
United States.
Media Contact: Investor Contact:
Maria Cantor Catherine Forte
(617) 768-6690 (617) 768-6881
SOURCE Genzyme Corporation
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CONTACT:
Media, Maria Cantor, +1-617-768-6690, or
Investors, Catherine Forte, +1-617-768-6881, both of Genzyme
Corporation
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